A leading medical device manufacturer sought to validate a new SCADA (Supervisory Control and Data Acquisition) system to be used in support of the assembly processes for both an upgraded product line and a new product line. This project launched the client’s initiative to leverage electronic process control technologies to improve efficiency and quality control […]
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The Challenge A medical technology company was upgrading their enterprise resource planning (ERP) software system to the latest Sage X3 platform in order to improve their efficiencies in accounting, distribution, and manufacturing. They would be implementing the Sage X3 platform as a SaaS (Software as a Service) with a browser-based interface. The scope of the […]
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Background: Often when contemplating a GMP application software project it is desirable to use the software vendor’s protocols to minimize cost. It would be natural to assume that the vendor’s protocols should provide a cost savings, as the vendor’s protocols had previously been executed as part of the testing to release the software for commercial […]
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The Challenge A pharmaceutical manufacturing company recently had several autoclave sterilization cycles that were very long in duration, resulting in premature failure of stopper and seal RTP bags. The cycles had been developed and validated years ago and the company did not have much in-house autoclave/sterilization expertise. Additionally, they only had one autoclave to support […]
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The Challenge A Fortune 500 medical technologies firm wanted to increase the production capacity for its products. The intention was to increase capacity with a new production line that was also prepared for future products to be added to the line with minimal changes. This plan saw the addition of a new SCADA controlled production […]
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The service engineering department of a leading medical device manufacturer developed a fully custom medical device programming system for distribution to its global service centers. This new programming system was a down-scaled version of a larger and more complex automated system that the client used in production for the testing and programming of electronically driven […]
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The Challenge A leading medical device manufacturer sought to add a new product to an existing production line. This required a retrofit of the previously validated line, requiring an assessment to determine if existing documentation met current regulatory standards. Additionally, new processes and simple fixtures were being added to the production line to accommodate the […]
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A Michigan based Fortune 500 company and leader in medical device technologies initiated a project to upgrade their existing Axeda® system application to the latest software version. Axeda®, recognized as a front-runner in machine-to-machine (M2M) technology on the Internet of Things (IoT) environment, offers a highly customizable software package with user interface, expression rules, and two-way […]
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The Challenge A Fortune 500 medical device manufacturer wanted to add a new laser welder to their production facility to improve manufacturing throughput and reduce scrap rate. The engineering staff at the medical device company were familiar with the equipment and its intended use; however, this model of laser welder had not been previously used […]
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Challenge A large mid-western pharmaceutical company embarked on a large capital project to increase their global production of several drugs. This expansion project required the construction of three (3) new buildings, as well as various utility and manufacturing equipment additions. The scope of Performance Validation’s commissioning and validation work including the following systems: Solution Performance […]
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